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SUPER: Study of Nutrition in Postpartum and Early Life Feeding Study

Sponsor
University of Texas at Austin (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06082921
Collaborator
National Cattlemen's Beef Association (Other)
20
Enrollment
2
Arms
6.9
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The first few months of life are a critical time for setting the health trajectory of both infants and mothers. It is essential that guidance provided to new families be based on the most rigorous scientific evidence available. Beef serves as a highly nutrient-rich option for lactating women. Plant-based beef products have similar nutrient profiles, and some consumers perceive them as a healthier alternative to traditional beef. This study aims to understand the different effects that beef and plant-based beef have on breastmilk composition, maternal glycemic control, maternal intake and satiety, and infant intake. Understanding the differences between beef and plant-based beef can help parents make informed decisions about optimal nutrition for their infants and themselves.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Beef Diet Intervention
  • Behavioral: Impossible Beef Diet Intervention
 N/A

Detailed Description

During the initial months of life, it is critical to set a path towards a healthy future for both the infant and mother.1-4 It is essential to provide new families with guidance that is grounded in the most rigorous scientific evidence possible. Although beef is a highly nutritious option for lactating women, there are now many plant-based beef products with similar nutrient profiles. Some consumers consider these substitutes to be a healthier alternative to beef. 5 "Plant-based" meat alternatives have become a common component of many Americans diets.5 A controlled trial is necessary to explore differences between beef and plant-based beef.

There have been no trials to establish differences in biochemical compounds available to breastfeeding infants in human milk based on lactating mothers' consumption of meat vs. plant-based meat. Furthermore, the amounts of compounds related to plant-based meat analogues that are transferred from a mother's diet into her breastmilk have also not been examined. While maternal weight status is increasingly linked to milk composition and differences in infant weight status,6-9 the role of diet in these associations has not been studied. These differences in breastmilk composition related to infant weight could explain inconsistent influence of breastfeeding on later weight status. Identifying possible biomarkers transferred from mothers to infants in breastmilk would elucidate potential biological mechanisms to explain the diet-weight relationship.

Finally, while some studies have linked metabolic dysregulation such as obesity or diabetes to negative alterations in breastmilk composition,3,7,10-13 we are not aware of any studies that consider whether the deleterious effects are attributable to glycemic control. Differences in ingredients and processing could lead to a differential effect on glycemic response in meat vs. plant-based meat.14-17 Such a finding would contribute to understanding the mechanisms by which maternal postnatal health and diet influence infant development.

This pilot study will help plan for future studies related to this population.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Basic Science
Official Title:
Study of nUtrition in Postpartum and EaRly Life (SUPER): Beef Feeding Trial
Anticipated Study Start Date :
Oct 5, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Beef Diet

Participants will eat 3 chef prepared meals a day that contain beef as main protein source. Snacks and desserts will be provided. All aspects of the meals, except for meat type (beef/impossible beef) will be the same during each arm. The base diet will be comprised of whole foods. Meals will meet acceptable macronutrient distribution ranges of the USDA.

Behavioral: Beef Diet Intervention
Participants will eat prepared meals including beef for 6 days. Participants will eat a habitual diet for 6 days prior to intervention.
Other Names:
  • Diet Intervention with Beef

    		•
    Experimental: Impossible Beef Diet

    Participants will eat 3 chef prepared meals a day that contain impossible beef as main protein source. Snacks and desserts will be provided. All aspects of the meals, except for meat type (beef/impossible beef) will be the same during each arm. The base diet will be comprised of whole foods. Meals will meet acceptable macronutrient distribution ranges of the USDA.

    Behavioral: Impossible Beef Diet Intervention
    Participants will eat prepared meals including impossible beef for one portion 6 days. Participants will eat a habitual diet for 6 days prior to intervention.
    Other Names:
  • Diet Intervention with Impossible Beef

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Breast Milk Fatty Acid Composition [12 days]

      Percent composition of fatty acids in breast milk samples during beef diet phase versus plant-based beef diet phase

    2. Breast Milk Processing Contaminants [12 days]

      Milk will be analyzed for processing contaminants

    3. Differences in Intake [25 days]

      Assess differences in intake using maternal consumption measured by food record, maternal satiety measured by survey, and maternal weight change measured at baseline and end of each condition; infant intake measured by weighed feeding

    4. Glycemic response to beef and impossible beef diet [25 days]

      Use CGMs to monitor glycemic response during dietary interventions and habitual diet

    Secondary Outcome Measures

    1. Relationship between glycemic response and breastmilk composition [25 days]

      Determine if elevated glycemic response alters breastmilk composition by comparing hormones in breastmilk to data collected from CGMs

    2. Cytokine composition and percentages in breast milk samples [25 days]

      Analyze amount of major cytokines present in breast milk samples across diet phases using Bioplex

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Comfortable communicating in English, both orally and in writing

    2. Infant aged between 6 and 12 weeks at enrollment

    3. Exclusively breastfeeding one infant

    4. Intention to continue breastfeeding through duration of the study

    5. BMI 25.0 - 29.9 kg/m2 at enrollment

    6. Willing to consume both meat & plant-based meat products

    7. Residing within ~10 mi radius of UT

    Exclusion Criteria:

    1. Pre-gestational diabetes, previous diagnosis of diabetes, or history of GDM (need specific diet)

    2. Negative delivery outcome (post-delivery stillbirth, infant mortality, NICU or ICU required)

    3. Began complementary feeding or intends to begin feeding solid food before completion of study, infant age <16 weeks.

    4. Active eating disorder (atypical diet quality, anxiety about diet and weight/body measurements and weight gain)

    5. Active substance abuse with alcohol or drugs by self-report (risk for poor adherence and could impact outcomes)

    6. Treatment with medications (e.g., corticosteroids, anti-psychotics) known to have metabolic/body weight effects

    7. BMI 30kg/m2 or BMI kg/m2

    8. Unable or unwilling to follow protocol

    9. Mom following vegetarian, vegan, or strict exclusion diet during pregnancy or lactation

    10. Excessive caffeine consumer

    11. Not a good candidate for a feeding trial (In general, if there are a variety of things indicating the potential participant might have a hard time meeting the requirements for the diet intervention. For example, if during screening, the potential participant indicates something that suggests they would be dishonest about their adherence to the diet.)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Texas at Austin
    • National Cattlemen's Beef Association

    Investigators

    • Principal Investigator: Marissa Burgermaster, PhD, University of Texas at Austin
    • Principal Investigator: Tom Brenna, PhD, University of Texas at Austin

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    University of Texas at Austin
    ClinicalTrials.gov Identifier:
    NCT06082921
    Other Study ID Numbers:
    • 00004375
    First Posted:
    Oct 13, 2023
    Last Update Posted:
    Oct 13, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Texas at Austin
    feeding trial
    breast milk
    postpartum
    fatty acids
    continuous glucose monitor
    beef
    plant-based meat

    Study Results

    No Results Posted as of Oct 13, 2023